欢迎访问电脑商情在线! 请免费注册
分享到





位置:首页 > 智能终端 > 文传商讯

Boehringer Ingelheim announces European Medicines Agency’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis

作者: CN-INFO   责任编辑:文传商讯 2021-10-29 17:08:00
来源:文传商讯关键字:null

The marketing authorization application (MAA) package includes results from the pivotal Effisayil-1 global trial

INGELHEIM, Germany--()--Boehringer Ingelheim announced today that the company’s marketing authorization application (MAA) for the treatment of flares in generalized pustular psoriasis (GPP), has been validated and is now under evaluation with the European Medicines Agency (EMA).

“GPP is a rare, life-threatening neutrophilic skin disease characterized by painful, sterile pus-filled blisters, that can suddenly appear over the body,” said Dr. Janine Lamar, Global Spesolimab Lead at Boehringer Ingelheim. “Despite its name, GPP is very different to the more common plaque psoriasis. With no approved treatments in the EU for GPP flares, acceptance of the application for review of spesolimab brings us one step closer to providing a targeted treatment for people with this distressing, unpredictable and painful skin condition.”

GPP is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus).1,2,3 The inflammation can also affect other parts of the body and can lead to infections or other organ complications that may be life-threatening.

There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life4 and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure, sepsis and even death.5

The marketing authorization application was based on the 12 week Effisayil-1 trial; a multi-center, double-blind, randomized, placebo-controlled trial that evaluated efficacy, safety, and tolerability of spesolimab (single dose 900 mg spesolimab i.v., with the option of a 2nd dose if symptoms persisted on Day 8) in patients experiencing a GPP flare.6 The study demonstrated superiority over placebo in pustular clearance after one week of treatment.

Please click on the following link for ‘Notes to Editors’:

http://www.boehringer-ingelheim.com/press-release/ema-filing-acceptance-and-validation-spesolimab

Contacts

Boehringer Ingelheim
Corporate Communications
Media + PR

Dr Julia Faass
Phone: +49 (6132) 77 95614
Fax: +49 (6132) 77 6601
Email: press@boehringer-ingelheim.com

Additional information
www.boehringer-ingelheim.com

相关新闻:
网友评论(0) 评论仅代表网友个人观点,不代表CBINews观点。
CBINews网友您好,欢迎发表评论:(注册 后发表评论,可就本文发起辩论,将会获得更多关注)
 CBINews网友  注册邮箱:  

CBI 友情链接:

至顶网 |  腾讯科技 |  凤凰科技 |  商业伙伴 |  移动信息化 |  企业网 |  中国软件网 |  CIO时代网 |  更多>>

整合营销 |  CBINews刊例 |  《电脑商情报》刊例 |  联系方式 |  版权声明 |  友情链接

内容版权所有:电脑商情在线 北京米迪亚广告有限公司

地址:北京市海淀区中关村南大街28号6层 联系电话:(010)62178877-218

商务、内容合作QQ:15528356 客服电话:800-886-4689

电脑商情信息服务集团 成都华好网景科技有限公司

ICP证:川B2-20070068-5 川预审H8VZ-RBP6-X228-T60Z号 北京市公安局海淀分局备案编号:1101083710